Medigus Ltd. (TASE:MDGS) has applied to the US Food and Drug Administration (FDA) to conduct a multi-center clinical trial for its flagship product, the SRS System for the treatment of Gastroesophageal Reflux Disease (GERD). The company applied for the trial under the 510(k) abbreviated procedure for medical devices.
Medigus earlier said that it hoped to begin marketing of the SRS System in the US in early 2008. The system is designed to replace surgical procedures for treating severe GERD, which involve stitching a part of the stomach lining around the lower part of the esophagus in order to create pressure to prevent the reflux of stomach acid. This procedure either requires opening the abdomen or laparoscopy.
The SRS System uses instead a guided camera endoscope inserted down the esophagus into the upper part of the stomach, where it fastens the stomach lining around the esophagus at the touch of a button, without the need for cutting or anesthesia.
Yesterday, Medigus received the results of the preliminary trial of the SRS System on ten patients, which demonstrated that the device was safe for use and that the results were similar to the results achieved through surgical procedures. The company filed for the multi-center clinical trial on the basis of the results of the preliminary trial.
Published by Globes [online], Israel business news - www.globes.co.il - on August 2, 2007
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